Long-term study of a quadrivalent human papillomavirus vaccine.

Abstract:

BACKGROUND:We present a long-term safety, immunogenicity, and effectiveness study of a quadrivalent human papillomavirus (HPV4) vaccine. METHODS:Sexually naive boys and girls aged 9 to 15 years (N = 1781) were assigned (2:1) to receive HPV4 vaccine or saline placebo at day 1 and months 2 and 6. At month 30, the placebo group (n = 482) received HPV4 vaccine following the same regimen and both cohorts were followed through month 96. Subjects ≥ 16 years were eligible for effectiveness evaluations. The primary objective was to evaluate the long-term anti-HPV6/11/16/18 serological levels. The secondary objective was to estimate vaccine effectiveness against HPV6/11/16/18-related persistent infection or disease. RESULTS:For each of the HPV4 vaccine types, vaccination-induced anti-HPV response persisted through month 96. Among 429 subjects who received HPV4 vaccine at a mean age of 12, none developed HPV6/11/16/18-related disease or persistent infection of ≥ 12 months' duration. Acquisition of new sexual partners (among those ≥ 16 years) was ∼1 per year. Subjects receiving HPV4 vaccine at month 30 (mean age 15 years) had a similar baseline rate of seropositivity to ≥ 1 of the 4 HPV types to those vaccinated at day 1 (mean age 12 years; 1.9% [9 of 474] vs 1.7% [20 of 1157]); however, 4 of the 9 subjects vaccinated at the later age were seropositive to 3 vaccine types, indicating previous HPV exposure. No new significant serious adverse events were observed for 8 years postvaccination in both genders. CONCLUSIONS:When administered to adolescents, the HPV4 vaccine demonstrated durability in clinically effective protection and sustained antibody titers over 8 years.

journal_name

Pediatrics

journal_title

Pediatrics

authors

Ferris D,Samakoses R,Block SL,Lazcano-Ponce E,Restrepo JA,Reisinger KS,Mehlsen J,Chatterjee A,Iversen OE,Sings HL,Shou Q,Sausser TA,Saah A

doi

10.1542/peds.2013-4144

subject

Has Abstract

pub_date

2014-09-01 00:00:00

pages

e657-65

issue

3

eissn

0031-4005

issn

1098-4275

pii

peds.2013-4144

journal_volume

134

pub_type

杂志文章,多中心研究,随机对照试验
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    更新日期:1998-03-01 00:00:00

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    pub_type: 杂志文章,随机对照试验

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    更新日期:2008-07-01 00:00:00

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    journal_title:Pediatrics

    pub_type:

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    pub_type: 临床试验,杂志文章,随机对照试验

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